Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hoffman LRF Hexapod Strut Recalled by Stryker GmbH Due to The press fit connection of the Angular Sleeve...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker GmbH directly.
Affected Products
Hoffman LRF Hexapod Strut, Extra Short 183mm-295mm, Model Number 4935-0-040. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted in loss of range of motion Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction Pseudoarthrosis or non-union of long bones Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction Correction of bony or soft tissue deformity Correction of segmental bony or soft tissue defects Joint arthrodesis Management of communicated intra-articular fractures of the distal radius Bone transport The Hoffmann LRF System is indicated in adults for: Osteotomy Revision procedure where other treatments or devices have been unsuccessful Bone reconstruction procedures Fusions and replantations of the foot Charcot foot reconstruction Lisfranc dislocations The typical LRF construct features two or more rings bridged by three to four telescopic struts with multiplanar, ball jointed fixation bolts. Once applied, the LRF can be unlocked for gross frame adjustment and fracture reduction. The LRF can be finely adjusted to aid in limb alignment and definitively locked to hold compression and reduction. If deemed appropriate, the LRF Telescopic Struts can provide up to 5mm of controlled dynamization. Original Statement OP-Tech H-ST-1_Rev2_HoffmannLRF_OpTech_2016-10690]
Quantity: 867
Why Was This Recalled?
The press fit connection of the Angular Sleeve and pin of the U-Joint and Click Lock did not meet specification. A dimensional discrepancy of the bore hole of the Angular Sleeve may cause a reduced press fit of the pin. This can result in partial of full displacement or loss of the pin and, accordingly, stability of the strut of the frame cannot be ensured.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker GmbH
Stryker GmbH has 68 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report